uvrc
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`9)‘. 5
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`2:10
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`g: ‘/4 DEPARTMENT OF HEALTH St HUMAN SERVICES
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`4.0
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`Public Health Service
`
`Food and Drug Administration
`1401 Rockville Pike
`Rockville MD 20852-1448
`
`Ou_r Reference No. 2 97-0244
`
`November 26,
`
`19 9 7
`
`M. David MacFar1ane, Ph.D.
`
`Genentech, Inc.
`
`1 DNA Way
`South San Francisco, CA 94080-4990
`
`Dear Dr. MacFarlane:
`
`Your biologics license application for Rituximab is approved effective this date. Genentech, Inc.,
`South San Franciso, California, is hereby authorized to manufacture and ship for sale, barter, or
`exchange in interstate and foreign commerce Rituximab under Department of Health and Human
`Services Biologics License No. 1048.
`
`Rituxumab is indicated for the treatment of patients with relapsed or refractory low-grade or
`follicular, B-cell non-Hodgkin’s lymphoma.
`
`Under this authorization, you are approved to manufacture Rituximab utilizing Formulated Bulk
`Rituximab G3or Further Manufacturing Use) manufactured by IDEC Pharmaceuticals Corp.
`(Biologics License No. 1235) under a shared manufacturing arrangement. Any addition or
`deletion of establishments involved in the shared manufacturing arrangement will require the
`submission of appropriate supporting data in order to ensure continued compliance with the
`approved standards for the manufacture of Rituximab.
`
`In accordance with approved labeling, your product will bear the tradename RITUXAN and will
`be marketed in 10 mL and 50 mL fill sizes.
`
`You are not currently required to submit samples of fixture lots of this product to the Center for
`Biologics Evaluation and Research (CBER) for release by the Director, CBER, under 21 CFR
`610.2. FDA will continue to monitor compliance with 21 CFR 610.1 requiring assay and release
`of only those lots that meet release specifications.
`
`The dating period for this product shall be 24 months from the date of manufacture when stored
`at 2-8°C. The date of manufacture shall be defined as the date of final sterile filtration of the
`product. Results of ongoing stability studies should be submitted throughout the dating period as
`they become available including the results of stability studies from the first three production lots.
`
`Mylan v. Genentech
`Mylan v. Genentech
`IPR2016-00710
`Genentech Exhibit 2127
`
`Genentech Exhibit 2127
`
`IPR2016-00710
`
`

`
`Page 2 - Dr. MacFarlane
`
`We acknowledge your written commitments of October 17, 1997 to:
`
`1.
`
`2.
`
`3.
`
`4.
`
`Submit the results of your study evaluating the time and temperature specifications for the
`transport of Rituximab Formulated Bulk and filled vials between buildings to CBER upon
`completion.
`
`Submit the results of the enviromnental monitoring survey to CBER by January 31, 1998.
`
`Include Lot E9054A in your ongoing Rituximab stability program.
`
`Establish a maximum fill duration for 500 mg Rituximab in 50 mL vials, supported by media
`fill data.
`
`Any changes in the supplier of the Formulated Bulk Rituximab (For Further Manufacturing Use),
`or in the manufacture, packaging or labeling of the product or in the manufacturing facilities will
`require the submission of information to your biologics license application for our review and
`written approval consistent with 21 CFR 601.12.
`
`It is requested that adverse experience reports be submitted in accordance with the adverse
`experience reporting requirements for licensed biological products (21 CFR 600.80) and that
`distribution reports be submitted as described (21 CFR 600.81). All adverse experience reports
`should be prominently identified according to 21 CFR 600.80 and be submitted to the Center for
`Biologics Evaluation and Research, HFM-210, Food and Drug Administration, 1401 Rockville
`Pike, Rockville, MD 20852-1448.
`
`Please submit three copies of all final printed labeling at the time of use and include part II of the
`label transmittal form with completed implementation information. In addition, you may wish to
`submit drafi copies of the proposed introductory advertising and promotional labeling with an
`FDA Form 2567 to the Center for Biologics Evaluation and Research, Advertising and
`Promotional Labeling Staff, HFM-202, 1401 Rockville Pike, Rockville, MD 20852-1448. Final
`printed advertising and promotional labeling should be submitted at the time of initial
`dissemination, accompanied by an FDA Form 2567. All promotional claims must be consistent
`with and not contrary to approved labeling. No comparative promotional claim or claim of
`superiority over other similar products should be made unless data to support such claims are
`submitted to and approved by the Center for Biologics Evaluation and Research.
`
`Sincerely yours,
`/
`
` ¢/
`
`Jay P. Siegel, M.D., FACP
`Director
`
`Office of Therapeutics
`Research and Review
`
`Center for Biologics
`Evaluation and Research